Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetat - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - liječenje od invazivnog kandidijaze kod odraslih i pedijatrijska bolesnika. liječenje od invazivnog аспергиллеза kod odraslih i pedijatrijski pacijenti koji резистентны ili netrpeljivosti Амфотерицина u, липидные lijekovi Амфотерицина b i/ili itrakonazol. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. za empirijske terapije namjeravanog gljivične infekcije (npr. candida ili аспергилл) u grozničav, još неоткупоренных za odrasle i pedijatrijska bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - vorikonazol - candidiasis; mycoses; aspergillosis - antimikotika za sustavnu uporabu - voriconazole, širokog spektra, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od 2 i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje u candidaemianon bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. Вифенд treba propisati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije. prevencija invazivne gljivične infekcije u grupi visokog rizika аллогенной transplantacije hematopoetski matičnih stanica (ТГСК) primatelja.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

biovit d.o.o. matka laginje 13 42000 varaždin -

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonazol - aspergillosis; candidiasis; mycoses - Антимикотиков za sistemsku primjenu, derivat триазола - voriconazole обширн-spektra, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od dvije i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje candidaemia u bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. voriconazole sporazuma treba primjenjivati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - vorikonazol - bacterial infections and mycoses; aspergillosis; candidiasis - antimikotika za sustavnu uporabu - voriconazole je širok raspon, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od 2 i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje candidaemia u bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. voriconazole treba propisati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije. prevencija invazivne gljivične infekcije u grupi visokog rizika аллогенной transplantacije hematopoetski matičnih stanica (ТГСК)primatelja.

Europska Unija - hrvatski - EMA (European Medicines Agency)

recordati ireland ltd. - lidokain, prilocaine - seksualna disfunkcija, fiziološka - anestetici - liječenje primarne prerane ejakulacije kod odraslih muškaraca.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenti za dermatitis, isključujući kortikosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - kandidijaza - antimikotika za sustavnu uporabu - Микамин indiciran za:odrasli, adolescenti ≥ 16 godina i elderlytreatment od invazivnog kandidijaza;liječenje kandidijaza jednjaka u bolesnika za koje внутривенная terapija;prevencija candida infekcije kod pacijenata koji su patili аллогенную transplantaciju гемопоэтических matičnih stanica ili transplantacije pacijenti, koji, kako se očekuje, нейтропении (apsolutni broj neutrofila < 500 stanica/μl) u roku od 10 dana ili više. djecu (uključujući i novorođenčad) i teen < 16 godina agetreatment od invazivnog kandidijaza. prevencija candida infekcije kod pacijenata koji su patili аллогенную transplantaciju гемопоэтических matičnih stanica ili transplantacije pacijenti, koji, kako se očekuje, нейтропении (apsolutni broj neutrofila < 500 stanica/μl) u roku od 10 dana ili više. rješenje koristiti lijek Микамин treba uzeti u obzir potencijalni rizik od razvoja tumora jetre . tako Микамин treba primijeniti samo ako su drugi antifungalni lijekovi nisu prikladni.